Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear

Overseen By Maria Noun, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bijan Najafi, PhD

Disqualifiers: Foot deformity, Amputation, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have unstable conditions with anticipated changes in your medication, you may not be eligible to participate.

What data supports the effectiveness of the treatment Orthofeet Shoes?

Research on orthopaedic and surgical shoes suggests that they can provide symptom relief and improve comfort for some patients, especially when patients are well-informed about their use. Additionally, foot orthoses have shown benefits in reducing pain and improving function in conditions like midfoot osteoarthritis. ^{1 2 3 4 5}

Is it safe to use Orthofeet Shoes or similar orthopedic footwear?

Research indicates that orthopedic shoes and foot orthotics are generally safe, with no significant negative effects on postural stability in older adults. However, user compliance and satisfaction can vary, and some users may experience no benefit or even worsening of symptoms. ^{2 6 7 8 9}

How do Orthofeet Shoes differ from other treatments for foot and ankle conditions?

Orthofeet Shoes are unique because they are designed to improve foot mechanics and provide comfort through features like rocker soles and custom orthoses, which can help with conditions like plantar fasciitis and diabetic neuropathy. Unlike standard shoes, they can be modified to accommodate specific foot shapes and conditions, offering a personalized approach to foot care. ^{10 11 12 13 14}

What is the purpose of this trial?

This trial tests special shoes called Orthofeet on adults aged 50+ with significant foot pain. The shoes have adjustable insoles to reduce foot pressure and pain, aiming to improve daily activities and overall well-being.

Eligibility Criteria

Inclusion Criteria

You experience foot pain in your heel, arch, or ball of foot and have reported it yourself.

50 years or older

Exclusion Criteria

Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance.

You have a foot ulcer and a significant foot deformity such as Charcot foot or Pes Cavus.

You have severe problems with thinking or memory, or are experiencing severe depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are involved in a 12-week randomized crossover trial wearing Orthofeet shoes and their own shoes

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Orthofeet Shoes

Participant Groups

Group I: Group AB Active Control 1 Intervention

Group AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes)

Group II: Group BA Active Control 1 Intervention

Group BA will be started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration

Who Is Running the Clinical Trial?

Bijan Najafi, PhD

Lead Sponsor

Trials

5

Recruited

280+

Orthofeet, Inc.

Collaborator

Trials

1

Recruited

50+

Findings from Research

Using static ankle-foot orthoses (AAFOs and PAFOs) with regular shoes significantly improved balance and symmetry in stroke patients, reducing center of pressure (CoP) sway compared to just wearing shoes or being barefoot.

PAFOs were found to be more effective than AAFOs in decreasing CoP sway and enhancing weight shifting, although both types of orthoses negatively affected the natural roll-over shape of the foot during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Static ankle-foot orthosis improves static balance and gait functions in hemiplegic patients after stroke. Chern, JS., Chang, HS., Lung, CW., et al.[2020]

In a study involving 142 adults with plantar fasciitis, both prefabricated and customized foot orthoses made from low-cost EVA foam showed significant improvement in pain after 8 weeks of use, indicating their effectiveness in treatment.

There was no significant difference in pain relief between the two types of orthoses, suggesting that low-cost prefabricated EVA inserts are a viable and effective option for treating uncomplicated plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Baldassin, V., Gomes, CR., Beraldo, PS.[2022]

Shoe modifications and foot orthoses are effective nonsurgical treatments for various foot and ankle conditions, improving gait and increasing mobility in patients with diabetes, arthritis, and other pathologies.

Custom orthoses come in four main types, each designed to provide specific benefits such as cushioning, support, and protection, making them versatile tools for both treatment and prevention of foot-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoe modification and the use of orthoses in the treatment of foot and ankle pathology. Janisse, DJ., Janisse, E.[2019]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Questionnaire study of the use of surgical shoes prescribed in a rheumatology outpatient clinic. [2015]

2. France pubmed.ncbi.nlm.nih.gov

Patient compliance and effect of orthopaedic shoes. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Static ankle-foot orthosis improves static balance and gait functions in hemiplegic patients after stroke. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Foot orthoses in the treatment of symptomatic midfoot osteoarthritis using clinical and biomechanical outcomes: a randomised feasibility study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Prefabricated foot orthoses compared to a placebo intervention for the treatment of chronic nonspecific low back pain: a study protocol for a randomised controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Compliance of patients wearing an orthotic device or orthopedic shoes: A systematic review. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Prevention of stress fractures using custom biomechanical shoe orthoses. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Effect of textured foot orthotics on static and dynamic postural stability in middle-aged females. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of Different Insole Materials on Kinetic and Kinematic Variables of the Walking Gait in Healthy People. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Shoe modification and the use of orthoses in the treatment of foot and ankle pathology. [2019]

12. Italy pubmed.ncbi.nlm.nih.gov

A new shoe for drop foot with automatic raising of the fore-foot. [2004]

13. England pubmed.ncbi.nlm.nih.gov

Understanding the role of foot biomechanics on regional foot orthosis deformation in flatfoot individuals during walking. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Can orthotic wedges change the lower-extremity and multi-segment foot kinematics during gait in people with plantar fasciitis? [2023]